Antipsychotic Induced Weight Gain, Non-alcoholic Steatohepatitis (NASH)
Conditions
Brief summary
The primary objective of this study is to evaluate the pharmacokinetics (PK) of miricorilant in the presence and absence of the strong cytochrome P450 \[(CYP) 2C19\] inhibitor, fluvoxamine, in healthy participants. Participants will receive a single dose of miricorilant under fed conditions with a standard breakfast after an overnight fast alone and in combination with once-daily doses of fluvoxamine. Blood samples will be collected at regular intervals for PK and safety analysis between admission and discharge from the clinical unit.
Interventions
DRUGMiricorilant
Miricorilant 6 x 100 mg coated tablets
DRUGFluvoxamine
Fluvoxamine 50 mg tablet
Sponsors
Corcept Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Able to understand a written informed consent * Willing and able to comply with all study requirements including potential CYP 2C19 genotyping analysis * Male participants must agree to use an adequate method of contraception * Healthy men or non-pregnant, non-lactating healthy women of non-childbearing potential * Body mass index of 19.0 to 32.0 kg/m\^2 * Body weight ≥50 kg.
Exclusion criteria
* Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients * Presence or history of clinically significant allergy requiring treatment. Hay fever is allowed unless it is active. * Significant skin disease, including rash, food allergy, eczema, psoriasis, or urticaria * History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease (except cholecystectomy), bleeding disorder, neurological or psychiatric disorder, as judged by the Investigator * Poor venous access that limits phlebotomy * Evidence of current SARS-CoV-2 infection * Clinically significant abnormal clinical chemistry, hematology, or urinalysis as judged by the Investigator. Participants with Gilbert's Syndrome are allowed. * Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results * Evidence of renal impairment at screening * Positive highly sensitive serum pregnancy test at screening or admission. Those who are pregnant or lactating will be excluded. A woman is considered of childbearing potential unless she is permanently sterile or is postmenopausal. * Clinically-significant ECG abnormalities or vital sign abnormalities at screening or at baseline * Have received any study drug in a clinical research study within 30 days (or 5 half-lives if longer) prior to first dose of study medication * Are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 2 g per day acetaminophen or COVID-19 vaccines) in the 14 days before study drug administration. Exceptions may apply. * Are currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within the last 12 months, or 3 months for inhaled products * Are taking, or have taken, selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors within 3 months before study drug administration * History of any drug or alcohol abuse in the past 2 years * Regular alcohol consumption in men \>21 units per week and women \>14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit, or 5 oz glass of wine) * Confirmed positive alcohol urine test at screening or admission * Current smokers and those who have smoked within the last 12 months * Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months * Positive drugs of abuse test result * Male participants with pregnant or lactating partners * Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study medication * Are, or are immediate family members of a study site or Sponsor employee * Failure to satisfy the investigator of fitness to participate for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration of miricorilant (Cmax) | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Days 1 and 10 |
| Area under the curve from time zero to the time of last measurable plasma concentration of miricorilant (AUC0-last) | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Days 1 and 10 |
| Area under the curve from time zero extrapolated to infinity of plasma concentration of miricorilant (AUC0-inf) | Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Days 1 and 10 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with one or more treatment-emergent adverse events (TEAEs) | Up to 30 days after study drug administration |
| Number of participants with a clinically-significant laboratory test abnormality | Up to Day 13 |
| Number of participants with one or more serious adverse events (SAEs) | Up to 30 days after study drug administration |
| Number of participants with a clinically-significant vital sign abnormality | Up to Day 13 |
Countries
United States
Outcome results
None listed